Prescription and over-the-counter medication recalls
Drug recalls come from the FDA's drug enforcement reports. They range from a wrong label to a product that could be harmful, and the risk level on each notice is the FDA's own classification. Never stop a prescribed medication on the strength of a recall notice alone — the notice will say whether to return it, and your prescriber or pharmacist decides what replaces it.
4,474 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Oct 13, 2021
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
FDA (openFDA drug enforcement)
Reported Oct 13, 2021
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Alpha-Tek LLC
FDA (openFDA drug enforcement)
Reported Oct 13, 2021
Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Amivas (us), LLC
FDA (openFDA drug enforcement)
Reported Oct 13, 2021
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Azurity Pharmaceuticals, Inc.
FDA (openFDA drug enforcement)
Reported Oct 13, 2021
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Rising Pharmaceuticals
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Health Packaging
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA LLC
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IntegraDose Compounding Services LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Jacobus Pharmaceutical Company Inc.
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%), Octisalate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Consumer, Inc.
19 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Monarch PCM, LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.New Vision Pharmaceuticals LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SigmaPharm Laboratories LLC
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Viatris
FDA (openFDA drug enforcement)
Reported Oct 6, 2021
Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers, Aconitum nap Fear* 87% Alcohol…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Washington Homeopathic Products, Inc.
38 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.American Health Packaging
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aurobindo Pharma USA Inc.
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avrio Health L.p
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Direct Rx
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition…
High riskUsing this product could cause serious injury, illness or death — stop using it now.DuPont Nutrition USA, Inc.
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
7 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Monarch PCM, LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Morton Grove Pharmaceuticals, Inc.
2 more products in this recall
FDA (openFDA drug enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.